Clinical trial · Interventional
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas
Molecular-Functional Imaging of Hypoxia in Childhood Sarcomas: Feasibility Steps Toward Personalized Medicine.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. Specifically, the investigators will compare the sensitivity of Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI and Magnetic Resonance Spectroscopy (MRS) with that of conventional MRI to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. Clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Rhabdo. Soft Tissue Sarcoma | Soft Tissue Sarcoma | ALIAS | 0.90 |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Oxygen Level Dependent [BOLD] MRI | Diagnostic Test | — | UNRESOLVED |
| Diffusion-Weighted [DW] MRI | Diagnostic Test | — | UNRESOLVED |
| Magnetic Resonance Spectroscopy [MRS] | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BOLD- DW- MRS
- description
- Blood Oxygen Level Dependent \[BOLD\], Diffusion-Weighted \[DW\] MRI, MR Spectroscopy \[MRS\]
- interventionNames
- Diagnostic Test: Blood Oxygen Level Dependent [BOLD] MRI
- Diagnostic Test: Diffusion-Weighted [DW] MRI
- Diagnostic Test: Magnetic Resonance Spectroscopy [MRS]
Primary outcomes (1)
- measure
- Number of participants with response to therapy
- timeFrame
- 1 year
- description
- Response will be assessed by measurements of tumor volume, percentage of BOLD signal changes, percentage of tumor necrosis, apparent diffusion coefficient, concentration of high-energy and low-energy phosphates in tumor.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma \[RMS\] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component; * Candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy Exclusion Criteria: * Patients with general contraindications for an MRI scan (metal foreign body, pacemaker, inability to tolerate an examination without sedation); * Patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy; * Patients with no clinical indication for neoadjuvant therapy prior to surgery; * Patients with chronic pulmonary disease; * Patients with other diagnosis confirmed after initial suspicion of RMS or non-RMS.
References
Publications (0)
Data not yet available